Clinical Investigation of Medical Devices

Clinical investigation of a device means the systematic study of an investigational medical device in or on human participants to assess its safety, performance or effectiveness. As per the Medical Device Rules of 2017 (MDR 2017), medical devices are categorised into four categories, depending upon the indications for use and risk level of the device. Medical devices are classified as low risk - Class A; low moderate risk- Class B; moderate high risk- Class C and high risk- Class D.


GroupDiscussion

Clinical Investigation of Medical Devices: Key Requirements

Clinical investigation is required for the Medical Devices which are new and are not approved by USA, UK, EU, Japan, Australia and Canada countries

No sponsor is allowed to conduct any clinical investigation without approval from CDSCO and institutional ethics committee. Clinical investigation is required for risky medical devices (Class B, Class C and Class D) without predicates. For Class A medical devices, data on clinical investigation may not be required, however in some cases the Central Licencing Authority (CLA), may consider data on clinical investigation necessary.

Clinical investigation may be waived when the investigational medical device is approved by the regulatory authorities of United Kingdom, United States of America, Australia, Canada or Japan and is marketed for at least two years in the above-mentioned country. However, in these cases the following should be fulfilled:

  • The CLA should be satisfied with the data of safety, performance and pharmacovigilance of the device approved in the respective country.

  • There should be no evidence or theoretical possibility, on the basis of existing knowledge, of any difference in the behaviour and performance of the device in Indian population.

  • The applicant would have to furnish an undertaking in writing to conduct post marketing clinical investigation/ performance with the objective of safety and performance of such investigational medical device as per protocol approved by CLA.

Application for grant of permission to conduct clinical investigation for investigational medical device - Form MD-22

An application for grant of permission to conduct clinical investigation for investigational medical device shall be made to the Central Licensing Authority in Form MD-22 by a sponsor and should be accompanied with information specified in the Seventh Schedule of the MDR 2017.

Permission to conduct clinical investigation - Form MD-23

The Central Licensing Authority, if satisfied, that the requirements have been complied with, grants permission to conduct clinical investigation for an investigational medical device in Form MD-23. After grant of permission, clinical investigation can be initiated based on clinical investigation plan duly approved by a registered Ethics Committee. Before enrolling the first participant, clinical investigation needs to be registered with the Clinical Trial Registry of India. The clinical investigation should be mandatorily initiated by enrolling first participant within a period of one year from the date of grant of permission, failing which prior permission from the CLA will be required to initiate clinical investigation.

Types of clinical investigation as per the new Medical Device Regulations, 2017

Pilot Clinical Investigation - Pilot clinical investigation is clinical investigation carried out for the first time in human participants. Pilot clinical investigations are conducted in a small study population (with the disease or condition being studied) to acquire specific essential information about a device before initiating the pivotal clinical investigation. Pilot clinical investigation is an exploratory study which provides an understanding of the performance and safety of a device but cannot provide definitive support for specific mechanistic or therapeutic claims. The objectives of a pilot clinical investigation typically include:

  • Assessing feasibility (e.g, preliminary device performance)

  • Exploring eligibility criteria and their practical application for pivotal controlled investigation, ascertaining potential harm (preliminary safety evaluations)

  • Studying device mechanism

  • Validating a method for determining an outcome measure

  • Using a defined device mechanism to validate a surrogate outcome measure

  • Evaluating the logistics of pivotal investigation for performance

Pivotal clinical investigation - Pivotal clinical investigation is a definitive study/ confirmatory study in which evidence is gathered to support the safety and effectiveness of the medical device for its intended use. Pivotal clinical investigation is conducted in a larger study population (with the disease or condition being studied). For pivotal study, data emerging from pilot clinical investigation is required to be submitted as well. For investigational medical device developed in India, clinical investigation is required to be carried out in India right from Pilot clinical investigation or first in human study and data generated should be submitted. For investigational medical device which does not have a predicate medical device but has been approved for sale or distribution in any country other than India, pivotal studies need to be carried out primarily to generate evidence of safety and effectiveness of the medical device in Indian patients when used as recommended in the prescribing information except in cases of investigational medical device classified under class A which shall be governed on case to case basis by the CLA. Prior to conduct of pivotal clinical investigation in Indian subjects, data from pilot study should be submitted to ensure that the pilot data is in conformity to the data already generated outside the country. Annual status report of each clinical investigation as to whether it is ongoing, completed or terminated should be submitted to CDSCO by the sponsor.

Reference Medical Device Rule. 2017. MINISTRY OF HEALTH AND FAMILY WELFARE. (Department of Health and Family Welfare)

Send us your Enquiry by filling the form below


*All the above fields are mandatory

Frequently Asked Questions

Which class of medical devices require clinical investigation in India?

Clinical investigation in India are typically required for risky medical devices (Class B, Class C and Class D) without predicates and may also be required for Class A medical devices.

Every person, sponsor, clinical research organisation, any other organisation or investigator conducting a clinical investigation or his agent holding a permission shall maintain the related data, record, registers and other documents for a period of seven years after completion of such investigation and shall furnish such information as may be required by the Central Licensing Authority or any other officer authorized by it in this behalf.

“Clinical investigation” means the systematic study of an investigational medical device in or on human participants to assess its safety, performance or effectiveness.

Form MD-22 is an application for grant of permission to conduct clinical investigation for investigational medical device.

A “clinical investigation plan” means a document which contains the information about the rationale, aims and objective, design and the proposed analysis, conduct, methodology including performance, management, adverse event, withdrawal and statistical consideration and record keeping pertaining to clinical investigation.

Pilot clinical investigation is defined as those clinical investigations which are used to acquire specific essential information about a device before beginning the pivotal clinical investigation. Pilot clinical investigation is exploratory study which may be conducted in a few numbers of patients with the disease or condition being studied before moving to large population and scope that give insight into the performance and safety of a device but cannot provide definitive support for specific mechanistic or therapeutic claims. The pivotal clinical investigation is a definitive study in which evidence is gathered to support the safety and effectiveness evaluation of the medical device for its intended use. Pivotal clinical investigation is confirmatory study that may be conducted in large number of patients with disease or condition being studied and scope to provide the effectiveness and adverse effects.

The Central Licensing Authority, if satisfied, may grant permission to conduct clinical investigation for an investigational medical device in Form MD-23.

Any medical device or new in vitro diagnostic medical device imported or manufactured, for the purpose of clinical investigation or clinical performance evaluation, test, evaluation, demonstration and training, shall be kept in containers bearing labels, indicating the name of the product or code number, batch or lot number, serial number wherever applicable, date of manufacture, use before date, storage conditions, name and address of the manufacturer, and the purpose for which it has been manufactured.

The license pertaining to the import for test, evaluation, clinical investigations is granted using form MD-17 by the Central Licensing Authority.

The results of clinical investigation may not be required to be submitted where the investigational medical device is approved by the regulatory authorities of either the United Kingdom or the United States of America or Australia or Canada or Japan or EU and the said device has been marketed for at least two years in that country and the Central Licencing Authority is satisfied with the data of safety, performance and pharmacovigilance of the device.


*All the above fields are mandatory
Enquire now